Quality Technician II

Job Description:

Summary:

Quality Technician II is an experienced quality professional responsible for independently executing advanced Quality Control

and Quality Assurance activities in support of manufacturing operations and the company Quality Management System. This

role supports compliance with applicable regulatory and quality standards including, but not limited to, ISO 9001, AS9100, and

FDA cGMP requirements.

In addition to routine inspection and testing, Quality Technician II serves as a technical resource for production teams, leads

defined quality investigations, supports audits, and contributes to continuous improvement initiatives. This position requires

minimal supervision and a strong understanding of manufacturing processes, documentation control, and regulatory

expectations.

This position requires on-site presence and is not eligible for remote work.

Essential Duties:

* Independently inspect, test, and accept or reject raw materials, intermediaries, and finished products using written

specifications, as established by company procedures.

* Work closely with Manufacturing Work Cells and other Quality Technicians to maintain production/product testing

schedules.

* Review Production Records to check the accuracy of data entered by production personnel such as batch yields, label counts,

raw materials additions etc.

* Review receiving documentation for shipments including components, chemical raw materials, bulk raw materials, and

finished goods: and if necessary then analyze samples before approval.

* Perform final approval of regulated batch records and master batch record updates.

* Assist in maintaining the Quality documentation system.

* Closing of batch tickets and issuing of Certificates of Analysis.

* Record data in quality logs, software package, and maintain accurate records in accordance with GMP good documentation

practices.

* Report production issues to Quality Manager and ask for guidance on next steps.

* Work in conjunction with operations and R&D teams, troubleshoot quality concerns that may arise on the production floor,

and are beyond of Quality Control duties.

* Perform production line checks and proactively identify potential quality or compliance issues.

* Maintenance of finished goods and raw material retains; manage purge and disposal activities according to retention

requirements.

* Provide writing reports and fill up forms when participating in identifying, investigating, and processing

Corrective/Preventive Actions, Customer Complaints, product Non-Conformance, Deviations, Quality Alerts, and 48 hrs.

Returned Goods Authorizations.

* Maintenance and housekeeping of laboratory testing equipment and surrounding areas in the lab by practicing 5S.

* Update and distribute documentation to production personnel.

* Participate in production pre-shift meetings and keep informed about changes in production schedule.

* Testing of customer samples.

* Assists with audits as needed.

* Assists with equipment calibration schedule.

* May be required, as needed, to work overtime, weekends or alternate shifts to support production.

* Follow all safety rules and take a leadership role in ensuring a safe environment.

* Assist in writing, editing, and training of standard operating procedures as needed.

* Supports Operations team to ensure quality standards.

* Follows the 80/20 philosophy in prioritizing daily tasks and serves as a contributing member of the Technical Operations

Staff.

* Professional represents company in a number of diverse settings including active participation in required audits and other

related meetings.

* Foster, communicate and exemplify the values of ITW; act with integrity and trust, operate with simplicity, treat everyone

with respect, take shared risk.

* Performs other duties as assigned.

Education & Experience:

* Minimum of a high school diploma or equivalent. College or Technical School education in the sciences or technical related

areas such as quality, regulatory a plus.

* Minimum of 3-5 years' work experience as a Quality Technician or related position.

* Demonstrated experience working in a facility regulated by FDA, cGMP, AS9100 and ISO
9001.

* Quality Technician experience in a chemical manufacturing facility a plus.

* Experience in conducting basic laboratory tests such as pH, viscosity, specific gravity, etc.

* Must be familiar with reading and following Standard Operating Procedures for production and laboratory processes.

* Must be organized and able to handle multiple tasks daily.

* Must be flexible to change.

* Must be reliable and capable of carrying out responsibilities with minimal supervision.

* Must be able to work in teams and individually.

* Proficient in Microsoft Office programs (Word, Excel, Power Point) and Outlook. Strong written, verbal and collaborative

communication skills

Work Environment:

* Must be capable of working in a standard office / laboratory environment. Must be capable of working for short periods

of time in a manufacturing environment, which may require exposure to heat, cold,…